FDA Product Code QEW: Peripheral Mechanical Thrombectomy With Aspiration

FDA product code QEW covers peripheral mechanical thrombectomy systems with aspiration.

These devices are designed to mechanically disrupt and remove thrombus from peripheral arteries and veins. They combine mechanical fragmentation with aspiration to restore blood flow in patients with acute limb ischemia or deep vein thrombosis.

QEW devices are Class II medical devices, regulated under 21 CFR 870.5150 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Penumbra, Inc., Inari Medical, Inc. and Inari Medical.